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NCT ID: NCT04898582 Active, not recruiting - Rosacea Clinical Trials

Clinical Benefit of M89PB in Subjects With Rosacea Associated With Erythema and Sensitive Skin

Start date: May 18, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to assess the efficacy of the product M89 probiotic fractions in improving the symptoms of rosacea patients with sensitive skin after 30 days of treatment, in comparison with an area treated with the habitual skin care product. 20 women with sensitive skin (positive reaction to stinging test), suffering from persistent centrofacial erythema of rosacea with no more than 3 papules and pustules apply the product on half a face, twice a day, for 30 days. The subjects use their habitual skin care product on the other side of the face. The product efficacy is supported by significant improvements in the mean basal values of the following instrumental parameters: skin hydration (increase), trans-epidermal water loss (decrease), skin erythema (a* parameter decrease). The efficacy and the tolerability of the product is also showed by a visual clinical assessment of the face skin conditions and by stinging test. Digital images of the face of the subjects were also taken at each control time. Furthermore, the volunteers express their judgement on the efficacy and the pleasantness of the product by means of a self-assessment questionnaire.

NCT ID: NCT04898153 Active, not recruiting - Clinical trials for End Stage Renal Disease

First-in-Human (FIH) Study of the Xeltis Hemodialysis Access Graft

aXess-FIH
Start date: June 10, 2021
Phase: N/A
Study type: Interventional

A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft.

NCT ID: NCT04896008 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of Sotatercept in Participants With PAH WHO FC III or FC IV at High Risk of Mortality (MK-7962-006/ZENITH)

ZENITH
Start date: December 1, 2021
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus maximum tolerated background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus maximum tolerated background PAH therapy) on time to first event of all cause death, lung transplantation, or PAH worsening-related hospitalization of ≥24 hours, in participants with World Health Organization (WHO) functional class (FC) III or FC IV PAH at high risk of mortality.

NCT ID: NCT04895748 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

DFF332 as a Single Agent and in Combination With Everolimus & Immuno-Oncology Agents in Advanced/Relapsed Renal Cancer & Other Malignancies

Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

This is first in human study of DFF332, a small molecule that targets a protein called HIF2α. By acting on HIF2α, DFF332 may be able to stop the growth of certain types of cancer. DFF332 will be tested at different doses as single agent and in combination with Everolimus (RAD001, an mTOR inhibitor), and also in combination with Spartalizumab (PDR001, an anti-PD1) plus Taminadenant (NIR178, an adenosine A2A receptor antagonist), in patients with advanced clear cell renal cell carcinoma and other malignancies with HIF stabilizing mutations.

NCT ID: NCT04895358 Active, not recruiting - Breast Neoplasms Clinical Trials

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Start date: June 18, 2021
Phase: Phase 3
Study type: Interventional

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer. The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.

NCT ID: NCT04893356 Active, not recruiting - Sarcoma Clinical Trials

Impact of O6-methylguanine-DNA Methyltransferase (MGMT) Promoter Methylation and MGMT Expression on Dacarbazine Treated Sarcoma Patients (MGMT)

MGMT
Start date: January 20, 2021
Phase:
Study type: Observational

MGMT study is a retrospective, non-profit, multi-center, observational study. The scientific objective of this study is to investigate whether MGMT expression or MGMT promoter methylation may represent a predictive marker for dacarbazine sensitivity in sarcoma patients.

NCT ID: NCT04893096 Active, not recruiting - Clinical trials for Membranous Nephropathy

MOR202 for Refractory MN

MONET
Start date: October 22, 2021
Phase: Phase 2
Study type: Interventional

Membranous nephropathy (MN) - the leading cause of nephrotic syndrome (NS) in adults - is an immune-mediated disease that results from the deposition of immunoglobulins and complement components onto the sub-epithelial layer of the glomerular capillary wall. The availability for clinical use of rituximab, a monoclonal antibody against the B-cell surface antigen CD20, offered the opportunity to test the effects of specific CD20-targeted intervention aimed to prevent B-cell dependent mechanisms resulting in the production of nephritogenic autoantibodies. Rituximab-induced B-cell depletion reduced proteinuria in eight patients with MN while avoiding the adverse effects of steroids and other immunosuppressants. Subsequent studies confirmed that rituximab is remarkably safer than non-specific immunosuppressive agents, including cyclosporine, and achieves remission in approximately two-thirds of patients with MN-associated nephrotic syndrome. After rituximab-induced remission, however, NS may relapse in approximately one third of patients. Thus, novel therapeutic options are needed for a substantial proportion of patients with MN who may fail rituximab therapy. Conceivably, in patients with MN refractory to CD20-targeted therapy, the production of nephritogenic autoantibodies is sustained by mechanisms that do not depend on autoreactive CD20+ B cells. Recently, it was shown that CD19-negative bone marrow plasma cells, which express CD38, are enriched in chronically inflamed tissue and secrete autoantibodies. Treatment of patients with MN with CD38-targeting antibodies may represent a new therapeutic approach. MOR202 is a fully human recombinant monoclonal antibody against CD38 that has demonstrated in-vitro and in-vivo efficacy in experimental models of multiple myeloma. Antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis are the principal mechanisms of action for MOR202-induced lysis of myeloma cells. The working hypothesis is that CD38-targeted therapy with MOR202 may abrogate autoantibody-dependent mechanisms in patients with plasma-cell mediated forms of MN who failed previous treatment with rituximab and second-generation anti-CD20 monoclonal antibodies such as ofatumumab. With this background, MOR202 therapy may have an indication for patients with MN and NS resistant to CD20 targeted therapy.

NCT ID: NCT04889729 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

GENOMED4ALL: Improving MDS Classification and Prognosis by AI

Start date: March 15, 2021
Phase:
Study type: Observational

Myelodysplastic syndromes (MDS) typically occur in elderly people. Current disese classifcation system and prognostic scores (International Prognostic Scoring System, IPSS) present limitations and in most cases fail to capture reliable prognostic information at individual level. Study of MDS has been rapidly transformed by genome characterization and there is increasing evidence that mutation screening may add significant information to currently available prognostic scores. The project will aim to develop artificial intelligence (AI)-based solutions to improve MDS classification and prognostication, through the implementation of a personalized medicine approach. In close collaboration with the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, FPA 739541), GENOMED4ALL involves multiple clinical partners from the network, while leveraging on healthcare information and repositories that will be gathered incorporating interoperability standards as promoted by ERN-EuroBloodNet central registry, the European Rare Blood Disorders Platform (ENROL, GA 947670).

NCT ID: NCT04886596 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

NCT ID: NCT04879368 Active, not recruiting - Clinical trials for Gastro-Oesophageal Cancer

RegoNivo vs Standard of Care Chemotherapy in AGOC

INTEGRATEIIb
Start date: June 1, 2021
Phase: Phase 3
Study type: Interventional

To determine if the regorafenib and nivolumab combination (RegoNivo) improves overall survival compared with current standard chemotherapy options in refractory AGOC.